CLASS I Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Forte Gamma Camera System is intended to produce images recalled
Philips Medical Systems (Cleveland) is recalling Forte Gamma Camera System is intended to produce images depicting the anatomical, distributed nationwide in the US. The recall was initiated on 19 Sep 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0214-2020
- FDA event ID
- 84009
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Sep 2019
- FDA classified
- 1 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Sep 2019 | Recall initiated by company | |
| 1 Nov 2019 | Classified by FDA | +43 days |
| 13 Nov 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Product as listed by the FDA
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Which lots are affected?
System Code: 882290 and 882291 All systems.
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 84009This product is part of a recall event; the main page for the event is Forte Gamma Camera System is intended to produce images recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide | |
| CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide | |
| CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide | |
| CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
More recalls from Philips Medical Systems (Cleveland)
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pinnacle Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle3 Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Other | 21 states |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
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