GE Healthcare Carescape Patient Data Module
Medical device recall Z-0060-2015. Published in FDA’s Enforcement Report on Oct 15, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 15, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Carescape Patient Data Module
68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA…
Every code shown here, 1,994 characters
Mfg Lot or Serial # SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA SA307030420GA SA307030423GA SA307050429GA SA307070436GR SA307070438GR SA307070441GR SA307070442GR SA307070446GA SA307070447GR SA307070448GA SA307070449GR SA307070450GR SA307070453GR SA307070454GR SA307070455GR SA307080459GA SA307080462GR SA307080463GR SA307080466GA SA307080467GA SA307080469GA SA307080472GA SA307080473GR SA307080477GR SA307080478GR SA307080484GA SA307080488GA SA307080489GA SA307080491GA SA307080493GR SA307080497GA SA307080498GR SA307080499GA SA307080502GR SA307080504GR SA307080508GR SA307080509GA SA307080510GR SA307080513GA SA307080520GR SA307080521GA SA307080522GR SA307080524GA SA307080525GR SA307080526GR SA307080533GR SA307105145GA SA307110544GA SA307110548GR SA307110556GA SA307110559GR SA307110560GR SA307110572GR SA307110575GR SA307110579GR SA307120587GR SA307140598GA SA307140599GR SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140614GA SA307140615GA SA307140618GR SA307140619GA SA307140621GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140637GA SA307140640GR SA307140642GA SA307150645GA SA307150651GA SA307150655GA SA307150656GA SA307150671GR SA307150675GA SA307150681GR SA307180694GR SA307180695GA SA307180696GR SA307180697GR SA307180698GA SA307180699GR SA307180701GA SA307180702GR SA307180704GR SA307180705GR SA307180706GR SA307180707GA SA307180708GA SA307190717GR SA307190722GA SA307190727GA SA307190729GR SA307190730GR SA307190731GR SA307190732GR SA307190733GA SA307190734GR SA307190736GR SA307190737GR SA307190738GR SA307190739GR SA307190741GR SA307190742GR SA307190743GR SA307190744GR SA307190745GR SA307190749GR SA307190750GR SA307190751GA SA307190752GA SA307190753GA SA307190754GA SA307190755GR SA307190756GR SA307190757GR SA307190759GA SA307190760GA SA307190761GA SA307190762GA SA307190764GR…
FDA’s list runs to 1,024,657 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORWAY, NETHERLAND, NEPAL, MYANMAR, MEXICO, MOROCCO, MALDOVA, MAURITIUS, MALAYSIA, LITHUANIA, LEBANON, BAHRAIN, KUWAIT, REPUBLIC OF KOREA, JAPAN, JORDAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUATEMALA, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT,ECUADOR, DENMARK, CECH REPUBLIC, COSTA RICA, COLOMBIA,, CHINA, CANADA, BULGARIA, BELGIUM BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out Delaware, Hawaii, North Dakota, South Dakota and Wyoming.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 19, 2014.
- FDA classified it on Oct 9, 2014.
- FDA’s Enforcement Report published it on Oct 15, 2014.
- FDA terminated it on Sep 13, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 1,024,657 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.